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The Specialist, Technical Operations engineer in this position will be responsible for providing technical support to one of the vaccine manufacturing areas within Technical Operations. Responsibilities include implementing continuous improvement projects as well as supporting equipment and investigations as required. The Specialist will work as an individual contributor, team or project lead.
- Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
- Provides technical support to manufacturing for complex problems and issues including process/equipment.
- Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
- Authors and updates technical and manufacturing documents necessary for engineering studies, change control.
- Supports regulatory inspection activities for the facility
- Provides on-the-floor support of operational and technical (process/equipment) issues on the shop floor.
- Performs deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
- Completes projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
- Supports team safety, environmental, and compliance objectives.
- Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.
- Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, and Planning.
Education Minimum Requirement:
- B.S. Degree in Engineering or Sciences
Required Experience and Skills:
- Minimum 2 years post-bachelor’s degree experience in regulated environment.
- Experience in deviation management and/or change control and/or equipment support and/or project support role.
- Highly developed communication, leadership and teamwork skills.
- Ability to manage projects/work to schedule/deadlines.
Preferred Experience and Skills:
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
- Change Control author
- Deviation Management Investigator